GeneSTAT.MDx Coccidioides Assay

FDA 510(k)

FDA Class 2 ·Microbiology

Morpheus-C

FDA 510(k)

FDA Class 2 ·Orthopedic

HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)

FDA 510(k)

FDA Class 2 ·Anesthesiology

ISIRONA MAGELLAN

FDA 510(k)

FDA Class 2 ·Cardiovascular

SICAGE™ System

FDA 510(k)

FDA Class 2 ·Orthopedic

MiniLoad Syringe

FDA 510(k)

FDA Class 2 ·General Hospital

Correx Software

FDA 510(k)

FDA Class 2 ·Orthopedic

MyEllevate

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LiteSaber Wire Torque Assist Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

The Entasis Dual-Lead Sacroiliac Implant

FDA 510(k)

FDA Class 2 ·Orthopedic

Dual Mode Infrared Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

COLLIMARE COLLIMATOR FAMILY

FDA 510(k)

FDA Class 2 ·Radiology

LANX FUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ENTity WiFi Video Nasopharyngoscope System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ECHOSOFT(TM)

FDA 510(k)

FDA Class 2 ·Radiology

CONSTRUX EXTERNAL FIXATION DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

VISU-LOCK 5MM CLIP APPLIER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CloudTMS for OCD

FDA 510(k)

FDA Class 2 ·Neurology